Positive Results Announced for Osteoporosis Drug

A recent clinical trial found that abaloparatide-SC can offer numerous benefits to postmenopausal women with osteoporosis.

Abaloparatide-SC is an experimental peptide that engages the parathyroid hormone receptor, and has shown bone building abilities. Included in the ACTIVE trial were 2463 postmenopausal women with osteoporosis, to determine the effect of abaloparatide-SC on vertebral and nonvertebral fracture risk.

Researchers found that the drug prevented bone fractures, regardless of bone density, age, or previous history of fracture, Radius Health announced in a press release. In the study, investigators discovered that abaloparatide-SC can also increase bone mineral density in this vulnerable population.

It is well known that menopause can reduce bone density and increase the risk of fracture. Other factors, such as aging or medications from other conditions, can increase this risk. Untreated osteoporosis can lead to fractures, which can cause pain, disability, and could even result in death, according to the press release.

Managing postmenopausal osteoporosis could prevent poor patient outcomes and save money for Medicare, which provides care for many elderly adults with osteoporosis. The safety and efficacy of abaloparatide-SC have yet to be established, according to the press release.

A New Drug Application for the drug is currently being reviewed by the FDA and is undergoing regulatory review by the European Medicines Agency.

“Results from the Phase 3 ACTIVE trial show that abaloparatide-SC may provide substantial benefit for a broad range of postmenopausal women with osteoporosis irrespective of their baseline risk factors, including age and prior fracture history,” said lead author Felicia Cosman, MD. “These data are important for the large number of postmenopausal women who may be at risk of a fracture and show that anabolic therapy could provide more consistent, potent and early benefits and may be the most efficient way for these patients to achieve ultimate bone mineral density goals.”